Skip to content
Triangle logo TriangleGet started
← Back to this collection

LABELS · 7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2

Riabni

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2026-07-22
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Fatal infusion-related reactions within 24 hours of rituximab infusion; approximately 80% of fatal reactions occurred with first infusion. Monitor patients and discontinue RIABNI infusion for severe reactions ( 5.1 ). Severe mucocutaneous reactions, some with fatal outcomes ( 5.2 ). Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death ( 5.3 ). Progressive multifocal leukoencephalopathy (PML) resulting in death ( 5.4 ). Infusion-Related Reactions Administration of rituximab products can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RIABNI infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ] . Severe Mucocutaneous Reactions Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products [see Warnings and Precautions (5.2) ] . Hepatitis B Virus (HBV) Reactivation HBV reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation and monitor patients during and after treatment with RIABNI. Discontinue RIABNI and concomitant medications in the event of HBV reactivation [see Warnings and Precautions (5.3) ] . Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products [see Warnings and Precautions (5.4) and Adverse Reactions (6.1) ] .

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE RIABNI is a CD20-directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens. Adult patients with Chronic Lymphocytic Leukemia (CLL) ( 1.2 ). Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC). Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately- to-severely- active RA who have inadequate response to one or more TNF antagonist therapies ( 1.3 ). Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids ( 1.4 ). Moderate to severe Pemphigus Vulgaris (PV) in adult patients ( 1.5 ). 1.1 Non-Hodgkin's Lymphoma (NHL) RIABNI is indicated for the treatment of adult patients with: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens. 1.2 Chronic Lymphocytic Leukemia (CLL) RIABNI, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL. 1.3 Rheumatoid Arthritis (RA) RIABNI, in combination with methotrexate, is indicated for the treatment of adult patients with moderately- to-severely- active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. 1.4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) RIABNI, in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA). 1.5 Pemphigus Vulgaris (PV) RIABNI is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.
Full extracted label fields
application numbers
  1. BLA761140
boxed warning exact
  1. WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Fatal infusion-related reactions within 24 hours of rituximab infusion; approximately 80% of fatal reactions occurred with first infusion. Monitor patients and discontinue RIABNI infusion for severe reactions ( 5.1 ). Severe mucocutaneous reactions, some with fatal outcomes ( 5.2 ). Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death ( 5.3 ). Progressive multifocal leukoencephalopathy (PML) resulting in death ( 5.4 ). Infusion-Related Reactions Administration of rituximab products can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RIABNI infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ] . Severe Mucocutaneous Reactions Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products [see Warnings and Precautions (5.2) ] . Hepatitis B Virus (HBV) Reactivation HBV reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation and monitor patients during and after treatment with RIABNI. Discontinue RIABNI and concomitant medications in the event of HBV reactivation [see Warnings and Precautions (5.3) ] . Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products [see Warnings and Precautions (5.4) and Adverse Reactions (6.1) ] .
brand names
  1. Riabni
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c4de7-0e5b-4f72-97ec-7a8d368f085f
generic names
  1. RITUXIMAB-ARRX
id
7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
indications and usage exact
  1. 1 INDICATIONS AND USAGE RIABNI is a CD20-directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens. Adult patients with Chronic Lymphocytic Leukemia (CLL) ( 1.2 ). Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC). Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately- to-severely- active RA who have inadequate response to one or more TNF antagonist therapies ( 1.3 ). Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids ( 1.4 ). Moderate to severe Pemphigus Vulgaris (PV) in adult patients ( 1.5 ). 1.1 Non-Hodgkin's Lymphoma (NHL) RIABNI is indicated for the treatment of adult patients with: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens. 1.2 Chronic Lymphocytic Leukemia (CLL) RIABNI, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL. 1.3 Rheumatoid Arthritis (RA) RIABNI, in combination with methotrexate, is indicated for the treatment of adult patients with moderately- to-severely- active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. 1.4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) RIABNI, in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA). 1.5 Pemphigus Vulgaris (PV) RIABNI is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Amgen, Inc
    matched search terms
    1. lymphoma
    2. leukemia
    package ndcs
    1. 55513-224-01
    2. 55513-224-21
    3. 55513-326-01
    4. 55513-326-21
    product ndcs
    1. 55513-224
    2. 55513-326
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Indications and Usage, Pemphigus Vulgaris (PV) ( 1.5 ) 6/2025 Dosage and Administration, Recommended Dose for (PV) ( 2.7 ) 6/2025 Dosage and Administration, Recommended Dose for Premedication and Prophylactic Medications ( 2.8 ) 6/2025 Warnings and Precautions, Infusion Related Reactions ( 5.1 ) 6/2025 Warnings and Precautions ( 5.12 ) 6/2025
    record type
    complete_spl_indications_section_candidate
    routes
    1. INTRAVENOUS
    rxcuis
    1. 2472327
    2. 2472332
    3. 2472335
    4. 2472336
    source batch
    file
    /private/tmp/cancer-full-research/indications/raw/labels-00400.json
    meta
    disclaimer
    Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
    last updated
    2026-09-09
    results
    limit
    100
    skip
    400
    total
    830
    sha256
    a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
    url
    https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=400&sort=id%3Aasc
    source url
    https://api.fda.gov/drug/label.json?search=id%3A%227e0a4bc5-9a5f-4b66-ab41-a4417988ccc2%22
    spl effective date
    2026-07-22
    spl effective time
    20260722
    spl set id
    da1c4de7-0e5b-4f72-97ec-7a8d368f085f
    spl version
    12
    substance names
    1. RITUXIMAB
    uniis
    1. 4F4X42SYQ6
    verification flags
    1. oncology_keyword_candidate_not_clinically_classified
    2. spl_text_not_verified_identical_to_latest_approved_label
    3. individual_indications_not_split_or_reconciled
    Drugs@FDA application source records
    1. application number
      BLA761140
      payload
      all indexed label documents
      1. Appl No
        761140
        Application Docs Date
        2020-12-17 00:00:00
        Application Docs ID
        65613
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        ORIG
      2. Appl No
        761140
        Application Docs Date
        2022-06-06 00:00:00
        Application Docs ID
        71216
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        SUPPL
      3. Appl No
        761140
        Application Docs Date
        2025-06-10 00:00:00
        Application Docs ID
        82521
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        4
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        761140
        Review Priority
        STANDARD
        Submission Class Code ID
        19
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2020-12-17 00:00:00
        Submission Type
        ORIG
        Submissions Public Notes
      2. Appl No
        761140
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2022-06-03 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        761140
        Review Priority
        N/A
        Submission Class Code ID
        1
        Submission No
        4
        Submission Status
        AP
        Submission Status Date
        2025-06-09 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      application number
      BLA761140
      approval interpretation
      Application linkage and approved submission are not indication-level current approval verification
      current indication status
      not_reconciled
      has approved submission record
      true
      latest approved submission date
      2025-06-09
      latest label selection rule
      max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
      latest posted label documents
      1. Appl No
        761140
        Application Docs Date
        2025-06-10 00:00:00
        Application Docs ID
        82521
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        4
        Submission Type
        SUPPL
      official application record
      Appl No
      761140
      Appl Public Notes
      Appl Type
      BLA
      Sponsor Name
      AMGEN INC
      openfda application present
      true
      products
      1. Active Ingredient
        RITUXIMAB-ARRX
        Appl No
        761140
        Drug Name
        RIABNI
        Form
        INJECTABLE;INJECTION
        Product No
        001
        Reference Drug
        2
        Reference Standard
        0
        Strength
        100MG/10ML(10MG/ML)
        marketing status
        1. Prescription

    Source passages and status connections

    Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

    Passage 1 · positive indication candidate
    application numbers
    1. BLA761140
    brand names
    1. Riabni
    classification reasons
    1. explicit_positive_indication_predicate
    2. tumor_or_malignant_hematology_words_in_positive_statement
    clinical review status
    pending
    content role
    positive_indication_candidate
    context span
    end
    358
    end exclusive
    true
    exact text
    1 INDICATIONS AND USAGE RIABNI is a CD20-directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and
    label id
    7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
    offset unit
    unicode_code_points
    source array index
    0
    source field
    indications_and_usage_exact
    source text sha256
    4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
    start
    0
    current approval status
    not_reconciled
    duplicate text group
    dup-1ba8016e7d2d88e472b5
    extraction review status
    automated_candidate_pending_source_review
    generic names
    1. RITUXIMAB-ARRX
    id
    ind-span-024d4658ec157e6c21c9
    label id
    7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
    positive predicate support span
    end
    78
    end exclusive
    true
    exact text
    is a CD20-directed cytolytic antibody indicated
    label id
    7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
    offset unit
    unicode_code_points
    source array index
    0
    source field
    indications_and_usage_exact
    source text sha256
    4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
    start
    31
    qualifier mentions
    1. context exact
      directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ).
      kind
      age
      polarity
      not_inferred
      span
      end
      115
      end exclusive
      true
      exact text
      Adult patients
      label id
      7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
      start
      101
    2. context exact
      1 INDICATIONS AND USAGE RIABNI is a CD20-directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymph
      kind
      biomarker
      polarity
      not_inferred
      span
      end
      80
      end exclusive
      true
      exact text
      CD20-directed cytolytic antibody indicated f
      label id
      7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
      start
      36
    regulatory links
      schema version
      0.1.0
      source batch sha256
      a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
      source defined aliases
        source span
        end
        158
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE RIABNI is a CD20-directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ).
        label id
        7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
        start
        0
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%227e0a4bc5-9a5f-4b66-ab41-a4417988ccc2%22
        spl effective date
        2026-07-22
        spl set id
        da1c4de7-0e5b-4f72-97ec-7a8d368f085f
        spl version
        12
        structured fields status
        not_extracted_no_values_inferred_from_mentions
        structured indication
        age
        Source null
        approval pathway
        Source null
        biomarker and test
        Source null
        disease stage
        Source null
        limitations
        Source null
        line
        Source null
        prior therapy
        Source null
        regimen
        Source null
        tumor histology
        Source null
        use intent
        tumor_directed_candidate
        Passage 2 · unclassified context
        application numbers
        1. BLA761140
        brand names
        1. Riabni
        classification reasons
        1. no_unambiguous_positive_indication_predicate
        clinical review status
        pending
        content role
        unclassified_context
        context span
        end
        451
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE RIABNI is a CD20-directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination
        label id
        7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
        start
        0
        current approval status
        not_reconciled
        duplicate text group
        dup-ceb94e1c6567d770509f
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. RITUXIMAB-ARRX
        id
        ind-span-bdcdd94e9d39c5828d53
        label id
        7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
        positive predicate support span
        Source null
        qualifier mentions
        1. context exact
          Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          250
          end exclusive
          true
          exact text
          CD20-positive B-cell NHL as a single agent
          label id
          7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
          start
          208
        2. context exact
          Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a sin
          kind
          stage_or_setting
          polarity
          not_inferred
          span
          end
          181
          end exclusive
          true
          exact text
          Relapsed or refractory
          label id
          7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
          start
          159
        3. context exact
          fractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.
          kind
          regimen
          polarity
          not_inferred
          span
          end
          250
          end exclusive
          true
          exact text
          as a single agent
          label id
          7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
          start
          233
        regulatory links
          schema version
          0.1.0
          source batch sha256
          a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
          source defined aliases
            source span
            end
            251
            end exclusive
            true
            exact text
            Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.
            label id
            7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
            start
            159
            source url
            https://api.fda.gov/drug/label.json?search=id%3A%227e0a4bc5-9a5f-4b66-ab41-a4417988ccc2%22
            spl effective date
            2026-07-22
            spl set id
            da1c4de7-0e5b-4f72-97ec-7a8d368f085f
            spl version
            12
            structured fields status
            not_extracted_no_values_inferred_from_mentions
            structured indication
            age
            Source null
            approval pathway
            Source null
            biomarker and test
            Source null
            disease stage
            Source null
            limitations
            Source null
            line
            Source null
            prior therapy
            Source null
            regimen
            Source null
            tumor histology
            Source null
            use intent
            unclear
            Passage 3 · positive indication candidate
            application numbers
            1. BLA761140
            brand names
            1. Riabni
            classification reasons
            1. inherited_predicate_from_same_label_section_requires_review
            2. no_tumor_directed_keyword_in_positive_statement
            clinical review status
            pending
            content role
            positive_indication_candidate
            context span
            end
            706
            end exclusive
            true
            exact text
            tolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untrea
            label id
            7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
            start
            52
            current approval status
            not_reconciled
            duplicate text group
            dup-30c2530375f7db6d281f
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. RITUXIMAB-ARRX
            id
            ind-span-4b34512fa2ef1446d934
            label id
            7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
            positive predicate support span
            end
            78
            end exclusive
            true
            exact text
            is a CD20-directed cytolytic antibody indicated
            label id
            7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
            start
            31
            qualifier mentions
            1. context exact
              Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and
              kind
              biomarker
              polarity
              not_inferred
              span
              end
              298
              end exclusive
              true
              exact text
              CD20-positive
              label id
              7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
              start
              285
            2. context exact
              Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent mainte
              kind
              prior_therapy_or_line
              polarity
              not_inferred
              span
              end
              432
              end exclusive
              true
              exact text
              Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab prod
              label id
              7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
              start
              252
            3. context exact
              Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.
              kind
              regimen
              polarity
              not_inferred
              span
              end
              490
              end exclusive
              true
              exact text
              in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent main
              label id
              7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
              start
              311
            regulatory links
              schema version
              0.1.0
              source batch sha256
              a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
              source defined aliases
                source span
                end
                506
                end exclusive
                true
                exact text
                Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.
                label id
                7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                start
                252
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%227e0a4bc5-9a5f-4b66-ab41-a4417988ccc2%22
                spl effective date
                2026-07-22
                spl set id
                da1c4de7-0e5b-4f72-97ec-7a8d368f085f
                spl version
                12
                structured fields status
                not_extracted_no_values_inferred_from_mentions
                structured indication
                age
                Source null
                approval pathway
                Source null
                biomarker and test
                Source null
                disease stage
                Source null
                limitations
                Source null
                line
                Source null
                prior therapy
                Source null
                regimen
                Source null
                tumor histology
                Source null
                use intent
                non_oncology_or_unclear_candidate
                Passage 4 · unclassified context
                application numbers
                1. BLA761140
                brand names
                1. Riabni
                classification reasons
                1. no_unambiguous_positive_indication_predicate
                clinical review status
                pending
                content role
                unclassified_context
                context span
                end
                888
                end exclusive
                true
                exact text
                NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
                label id
                7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                start
                307
                current approval status
                not_reconciled
                duplicate text group
                dup-7f978299f4a92753070e
                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. RITUXIMAB-ARRX
                id
                ind-span-c7365f88a48f397b93ad
                label id
                7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                positive predicate support span
                Source null
                qualifier mentions
                1. context exact
                  Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophospha
                  kind
                  biomarker
                  polarity
                  not_inferred
                  span
                  end
                  575
                  end exclusive
                  true
                  exact text
                  CD20-positive
                  label id
                  7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                  start
                  562
                2. context exact
                  ow-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
                  kind
                  prior_therapy_or_line
                  polarity
                  not_inferred
                  span
                  end
                  687
                  end exclusive
                  true
                  exact text
                  first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy
                  label id
                  7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                  start
                  612
                3. context exact
                  uding stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
                  kind
                  regimen
                  polarity
                  not_inferred
                  span
                  end
                  687
                  end exclusive
                  true
                  exact text
                  as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy
                  label id
                  7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                  start
                  588
                regulatory links
                  schema version
                  0.1.0
                  source batch sha256
                  a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                  source defined aliases
                    source span
                    end
                    688
                    end exclusive
                    true
                    exact text
                    Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
                    label id
                    7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                    start
                    507
                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%227e0a4bc5-9a5f-4b66-ab41-a4417988ccc2%22
                    spl effective date
                    2026-07-22
                    spl set id
                    da1c4de7-0e5b-4f72-97ec-7a8d368f085f
                    spl version
                    12
                    structured fields status
                    not_extracted_no_values_inferred_from_mentions
                    structured indication
                    age
                    Source null
                    approval pathway
                    Source null
                    biomarker and test
                    Source null
                    disease stage
                    Source null
                    limitations
                    Source null
                    line
                    Source null
                    prior therapy
                    Source null
                    regimen
                    Source null
                    tumor histology
                    Source null
                    use intent
                    unclear
                    Passage 5 · positive indication candidate
                    application numbers
                    1. BLA761140
                    brand names
                    1. Riabni
                    classification reasons
                    1. inherited_predicate_from_same_label_section_requires_review
                    2. no_tumor_directed_keyword_in_positive_statement
                    clinical review status
                    pending
                    content role
                    positive_indication_candidate
                    context span
                    end
                    1087
                    end exclusive
                    true
                    exact text
                    ntenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens. Adult patients with Chronic Lymphocytic Leukemia (CLL) ( 1.2 ). Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC). Rheumatoid Art
                    label id
                    7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                    start
                    489
                    current approval status
                    not_reconciled
                    duplicate text group
                    dup-f7ed6727ededa3051e9f
                    extraction review status
                    automated_candidate_pending_source_review
                    generic names
                    1. RITUXIMAB-ARRX
                    id
                    ind-span-500410cb569f87e09d6d
                    label id
                    7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                    positive predicate support span
                    end
                    78
                    end exclusive
                    true
                    exact text
                    is a CD20-directed cytolytic antibody indicated
                    label id
                    7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                    start
                    31
                    qualifier mentions
                    1. context exact
                      Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP)
                      kind
                      biomarker
                      polarity
                      not_inferred
                      span
                      end
                      776
                      end exclusive
                      true
                      exact text
                      CD20-positive NHL in combination with cyclop
                      label id
                      7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                      start
                      732
                    2. context exact
                      Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
                      kind
                      prior_therapy_or_line
                      polarity
                      not_inferred
                      span
                      end
                      869
                      end exclusive
                      true
                      exact text
                      Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chem
                      label id
                      7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                      start
                      689
                    3. context exact
                      reviously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
                      kind
                      regimen
                      polarity
                      not_inferred
                      span
                      end
                      886
                      end exclusive
                      true
                      exact text
                      in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens
                      label id
                      7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                      start
                      750
                    regulatory links
                      schema version
                      0.1.0
                      source batch sha256
                      a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                      source defined aliases
                        source span
                        end
                        887
                        end exclusive
                        true
                        exact text
                        Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
                        label id
                        7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                        start
                        689
                        source url
                        https://api.fda.gov/drug/label.json?search=id%3A%227e0a4bc5-9a5f-4b66-ab41-a4417988ccc2%22
                        spl effective date
                        2026-07-22
                        spl set id
                        da1c4de7-0e5b-4f72-97ec-7a8d368f085f
                        spl version
                        12
                        structured fields status
                        not_extracted_no_values_inferred_from_mentions
                        structured indication
                        age
                        Source null
                        approval pathway
                        Source null
                        biomarker and test
                        Source null
                        disease stage
                        Source null
                        limitations
                        Source null
                        line
                        Source null
                        prior therapy
                        Source null
                        regimen
                        Source null
                        tumor histology
                        Source null
                        use intent
                        non_oncology_or_unclear_candidate
                        Passage 6 · unclassified context
                        application numbers
                        1. BLA761140
                        brand names
                        1. Riabni
                        classification reasons
                        1. no_unambiguous_positive_indication_predicate
                        clinical review status
                        pending
                        content role
                        unclassified_context
                        context span
                        end
                        1151
                        end exclusive
                        true
                        exact text
                        Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens. Adult patients with Chronic Lymphocytic Leukemia (CLL) ( 1.2 ). Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC). Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients w
                        label id
                        7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                        start
                        688
                        current approval status
                        not_reconciled
                        duplicate text group
                        dup-d890ac2d487c55a19727
                        extraction review status
                        automated_candidate_pending_source_review
                        generic names
                        1. RITUXIMAB-ARRX
                        id
                        ind-span-06ab3867a89ea16583f2
                        label id
                        7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                        positive predicate support span
                        Source null
                        qualifier mentions
                        1. context exact
                          Adult patients with Chronic Lymphocytic Leukemia (CLL) ( 1.2 ).
                          kind
                          age
                          polarity
                          not_inferred
                          span
                          end
                          902
                          end exclusive
                          true
                          exact text
                          Adult patients
                          label id
                          7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                          start
                          888
                        regulatory links
                          schema version
                          0.1.0
                          source batch sha256
                          a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                          source defined aliases
                            source span
                            end
                            951
                            end exclusive
                            true
                            exact text
                            Adult patients with Chronic Lymphocytic Leukemia (CLL) ( 1.2 ).
                            label id
                            7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                            start
                            888
                            source url
                            https://api.fda.gov/drug/label.json?search=id%3A%227e0a4bc5-9a5f-4b66-ab41-a4417988ccc2%22
                            spl effective date
                            2026-07-22
                            spl set id
                            da1c4de7-0e5b-4f72-97ec-7a8d368f085f
                            spl version
                            12
                            structured fields status
                            not_extracted_no_values_inferred_from_mentions
                            structured indication
                            age
                            Source null
                            approval pathway
                            Source null
                            biomarker and test
                            Source null
                            disease stage
                            Source null
                            limitations
                            Source null
                            line
                            Source null
                            prior therapy
                            Source null
                            regimen
                            Source null
                            tumor histology
                            Source null
                            use intent
                            unclear
                            Passage 7 · unclassified context
                            application numbers
                            1. BLA761140
                            brand names
                            1. Riabni
                            classification reasons
                            1. no_unambiguous_positive_indication_predicate
                            clinical review status
                            pending
                            content role
                            unclassified_context
                            context span
                            end
                            1272
                            end exclusive
                            true
                            exact text
                            combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens. Adult patients with Chronic Lymphocytic Leukemia (CLL) ( 1.2 ). Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC). Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately- to-severely- active RA who have inadequate response to one or more TNF antagonist therapies ( 1.3 ). Gran
                            label id
                            7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                            start
                            752
                            current approval status
                            not_reconciled
                            duplicate text group
                            dup-0df19e07af19bf2e264a
                            extraction review status
                            automated_candidate_pending_source_review
                            generic names
                            1. RITUXIMAB-ARRX
                            id
                            ind-span-972949082f72aa111dd9
                            label id
                            7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                            positive predicate support span
                            Source null
                            qualifier mentions
                            1. context exact
                              Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC).
                              kind
                              biomarker
                              polarity
                              not_inferred
                              span
                              end
                              1040
                              end exclusive
                              true
                              exact text
                              CD20-positive CLL in combination with fludar
                              label id
                              7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                              start
                              996
                            2. context exact
                              Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC).
                              kind
                              prior_therapy_or_line
                              polarity
                              not_inferred
                              span
                              end
                              1071
                              end exclusive
                              true
                              exact text
                              Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)
                              label id
                              7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                              start
                              952
                            3. context exact
                              eviously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC).
                              kind
                              regimen
                              polarity
                              not_inferred
                              span
                              end
                              1071
                              end exclusive
                              true
                              exact text
                              in combination with fludarabine and cyclophosphamide (FC)
                              label id
                              7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                              start
                              1014
                            regulatory links
                              schema version
                              0.1.0
                              source batch sha256
                              a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                              source defined aliases
                                source span
                                end
                                1072
                                end exclusive
                                true
                                exact text
                                Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC).
                                label id
                                7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                start
                                952
                                source url
                                https://api.fda.gov/drug/label.json?search=id%3A%227e0a4bc5-9a5f-4b66-ab41-a4417988ccc2%22
                                spl effective date
                                2026-07-22
                                spl set id
                                da1c4de7-0e5b-4f72-97ec-7a8d368f085f
                                spl version
                                12
                                structured fields status
                                not_extracted_no_values_inferred_from_mentions
                                structured indication
                                age
                                Source null
                                approval pathway
                                Source null
                                biomarker and test
                                Source null
                                disease stage
                                Source null
                                limitations
                                Source null
                                line
                                Source null
                                prior therapy
                                Source null
                                regimen
                                Source null
                                tumor histology
                                Source null
                                use intent
                                unclear
                                Passage 8 · unclassified context
                                application numbers
                                1. BLA761140
                                brand names
                                1. Riabni
                                classification reasons
                                1. no_unambiguous_positive_indication_predicate
                                clinical review status
                                pending
                                content role
                                unclassified_context
                                context span
                                end
                                1467
                                end exclusive
                                true
                                exact text
                                rapy regimens. Adult patients with Chronic Lymphocytic Leukemia (CLL) ( 1.2 ). Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC). Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately- to-severely- active RA who have inadequate response to one or more TNF antagonist therapies ( 1.3 ). Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids ( 1.4 ). Moderate to severe Pemphigus Vulgar
                                label id
                                7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                start
                                873
                                current approval status
                                not_reconciled
                                duplicate text group
                                dup-1001163ab5dff7370920
                                extraction review status
                                automated_candidate_pending_source_review
                                generic names
                                1. RITUXIMAB-ARRX
                                id
                                ind-span-8a4e6a32f44796be0125
                                label id
                                7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                positive predicate support span
                                Source null
                                qualifier mentions
                                1. context exact
                                  eumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately- to-severely- active RA who have inadequate
                                  kind
                                  age
                                  polarity
                                  not_inferred
                                  span
                                  end
                                  1149
                                  end exclusive
                                  true
                                  exact text
                                  adult patients
                                  label id
                                  7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                  start
                                  1135
                                2. context exact
                                  Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately- to-severely- active RA who have inadequate response to
                                  kind
                                  biomarker
                                  polarity
                                  not_inferred
                                  span
                                  end
                                  1162
                                  end exclusive
                                  true
                                  exact text
                                  methotrexate in adult patients with moderat
                                  label id
                                  7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                  start
                                  1119
                                3. context exact
                                  Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately- to-severely- active RA who have inadequate response to one or more TNF antagonist therapies ( 1.3 ).
                                  kind
                                  regimen
                                  polarity
                                  not_inferred
                                  span
                                  end
                                  1262
                                  end exclusive
                                  true
                                  exact text
                                  in combination with methotrexate in adult patients with moderately- to-severely- active RA who have inadequate response to one or more TNF antagonist therapies ( 1
                                  label id
                                  7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                  start
                                  1099
                                regulatory links
                                  schema version
                                  0.1.0
                                  source batch sha256
                                  a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                                  source defined aliases
                                    source span
                                    end
                                    1267
                                    end exclusive
                                    true
                                    exact text
                                    Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately- to-severely- active RA who have inadequate response to one or more TNF antagonist therapies ( 1.3 ).
                                    label id
                                    7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                    start
                                    1073
                                    source url
                                    https://api.fda.gov/drug/label.json?search=id%3A%227e0a4bc5-9a5f-4b66-ab41-a4417988ccc2%22
                                    spl effective date
                                    2026-07-22
                                    spl set id
                                    da1c4de7-0e5b-4f72-97ec-7a8d368f085f
                                    spl version
                                    12
                                    structured fields status
                                    not_extracted_no_values_inferred_from_mentions
                                    structured indication
                                    age
                                    Source null
                                    approval pathway
                                    Source null
                                    biomarker and test
                                    Source null
                                    disease stage
                                    Source null
                                    limitations
                                    Source null
                                    line
                                    Source null
                                    prior therapy
                                    Source null
                                    regimen
                                    Source null
                                    tumor histology
                                    Source null
                                    use intent
                                    unclear
                                    Passage 9 · unclassified context
                                    application numbers
                                    1. BLA761140
                                    brand names
                                    1. Riabni
                                    classification reasons
                                    1. no_unambiguous_positive_indication_predicate
                                    clinical review status
                                    pending
                                    content role
                                    unclassified_context
                                    context span
                                    end
                                    1631
                                    end exclusive
                                    true
                                    exact text
                                    FC). Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately- to-severely- active RA who have inadequate response to one or more TNF antagonist therapies ( 1.3 ). Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids ( 1.4 ). Moderate to severe Pemphigus Vulgaris (PV) in adult patients ( 1.5 ). 1.1 Non-Hodgkin's Lymphoma (NHL) RIABNI is indicated for the treatment of adult patients with: Relapsed or refractory, low-grade
                                    label id
                                    7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                    start
                                    1068
                                    current approval status
                                    not_reconciled
                                    duplicate text group
                                    dup-9250a5931ec10bf887e4
                                    extraction review status
                                    automated_candidate_pending_source_review
                                    generic names
                                    1. RITUXIMAB-ARRX
                                    id
                                    ind-span-5d150ad6f5f13f451544
                                    label id
                                    7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                    positive predicate support span
                                    Source null
                                    qualifier mentions
                                    1. context exact
                                      ner's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids ( 1.4 ).
                                      kind
                                      age
                                      polarity
                                      not_inferred
                                      span
                                      end
                                      1386
                                      end exclusive
                                      true
                                      exact text
                                      adult patients
                                      label id
                                      7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                      start
                                      1372
                                    2. context exact
                                      tosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids ( 1.4 ).
                                      kind
                                      regimen
                                      polarity
                                      not_inferred
                                      span
                                      end
                                      1426
                                      end exclusive
                                      true
                                      exact text
                                      in combination with glucocorticoids ( 1
                                      label id
                                      7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                      start
                                      1387
                                    regulatory links
                                      schema version
                                      0.1.0
                                      source batch sha256
                                      a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                                      source defined aliases
                                        source span
                                        end
                                        1431
                                        end exclusive
                                        true
                                        exact text
                                        Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids ( 1.4 ).
                                        label id
                                        7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                        start
                                        1268
                                        source url
                                        https://api.fda.gov/drug/label.json?search=id%3A%227e0a4bc5-9a5f-4b66-ab41-a4417988ccc2%22
                                        spl effective date
                                        2026-07-22
                                        spl set id
                                        da1c4de7-0e5b-4f72-97ec-7a8d368f085f
                                        spl version
                                        12
                                        structured fields status
                                        not_extracted_no_values_inferred_from_mentions
                                        structured indication
                                        age
                                        Source null
                                        approval pathway
                                        Source null
                                        biomarker and test
                                        Source null
                                        disease stage
                                        Source null
                                        limitations
                                        Source null
                                        line
                                        Source null
                                        prior therapy
                                        Source null
                                        regimen
                                        Source null
                                        tumor histology
                                        Source null
                                        use intent
                                        unclear
                                        Passage 10 · unclassified context
                                        application numbers
                                        1. BLA761140
                                        brand names
                                        1. Riabni
                                        classification reasons
                                        1. no_unambiguous_positive_indication_predicate
                                        clinical review status
                                        pending
                                        content role
                                        unclassified_context
                                        context span
                                        end
                                        1701
                                        end exclusive
                                        true
                                        exact text
                                        e TNF antagonist therapies ( 1.3 ). Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids ( 1.4 ). Moderate to severe Pemphigus Vulgaris (PV) in adult patients ( 1.5 ). 1.1 Non-Hodgkin's Lymphoma (NHL) RIABNI is indicated for the treatment of adult patients with: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent. Previously
                                        label id
                                        7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                        start
                                        1232
                                        current approval status
                                        not_reconciled
                                        duplicate text group
                                        dup-8397e22d763b4f0aeefa
                                        extraction review status
                                        automated_candidate_pending_source_review
                                        generic names
                                        1. RITUXIMAB-ARRX
                                        id
                                        ind-span-e1eedacdc873290d1abb
                                        label id
                                        7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                        positive predicate support span
                                        Source null
                                        qualifier mentions
                                        1. context exact
                                          Moderate to severe Pemphigus Vulgaris (PV) in adult patients ( 1.5 ).
                                          kind
                                          age
                                          polarity
                                          not_inferred
                                          span
                                          end
                                          1492
                                          end exclusive
                                          true
                                          exact text
                                          adult patients
                                          label id
                                          7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                          offset unit
                                          unicode_code_points
                                          source array index
                                          0
                                          source field
                                          indications_and_usage_exact
                                          source text sha256
                                          4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                          start
                                          1478
                                        regulatory links
                                          schema version
                                          0.1.0
                                          source batch sha256
                                          a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                                          source defined aliases
                                            source span
                                            end
                                            1501
                                            end exclusive
                                            true
                                            exact text
                                            Moderate to severe Pemphigus Vulgaris (PV) in adult patients ( 1.5 ).
                                            label id
                                            7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                            start
                                            1432
                                            source url
                                            https://api.fda.gov/drug/label.json?search=id%3A%227e0a4bc5-9a5f-4b66-ab41-a4417988ccc2%22
                                            spl effective date
                                            2026-07-22
                                            spl set id
                                            da1c4de7-0e5b-4f72-97ec-7a8d368f085f
                                            spl version
                                            12
                                            structured fields status
                                            not_extracted_no_values_inferred_from_mentions
                                            structured indication
                                            age
                                            Source null
                                            approval pathway
                                            Source null
                                            biomarker and test
                                            Source null
                                            disease stage
                                            Source null
                                            limitations
                                            Source null
                                            line
                                            Source null
                                            prior therapy
                                            Source null
                                            regimen
                                            Source null
                                            tumor histology
                                            Source null
                                            use intent
                                            unclear
                                            Passage 11 · positive indication candidate
                                            application numbers
                                            1. BLA761140
                                            brand names
                                            1. Riabni
                                            classification reasons
                                            1. explicit_positive_indication_predicate
                                            2. tumor_or_malignant_hematology_words_in_positive_statement
                                            clinical review status
                                            pending
                                            content role
                                            positive_indication_candidate
                                            context span
                                            end
                                            1890
                                            end exclusive
                                            true
                                            exact text
                                            GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids ( 1.4 ). Moderate to severe Pemphigus Vulgaris (PV) in adult patients ( 1.5 ). 1.1 Non-Hodgkin's Lymphoma (NHL) RIABNI is indicated for the treatment of adult patients with: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination
                                            label id
                                            7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                            start
                                            1302
                                            current approval status
                                            not_reconciled
                                            duplicate text group
                                            dup-a31967a2123b07dcac5a
                                            extraction review status
                                            automated_candidate_pending_source_review
                                            generic names
                                            1. RITUXIMAB-ARRX
                                            id
                                            ind-span-ebb5c498933957a33bbd
                                            label id
                                            7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                            positive predicate support span
                                            end
                                            1554
                                            end exclusive
                                            true
                                            exact text
                                            is indicated
                                            label id
                                            7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                            start
                                            1542
                                            qualifier mentions
                                            1. context exact
                                              n's Lymphoma (NHL) RIABNI is indicated for the treatment of adult patients with: Relapsed or refractory, low-grade or follicular, CD20
                                              kind
                                              age
                                              polarity
                                              not_inferred
                                              span
                                              end
                                              1590
                                              end exclusive
                                              true
                                              exact text
                                              adult patients
                                              label id
                                              7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                              offset unit
                                              unicode_code_points
                                              source array index
                                              0
                                              source field
                                              indications_and_usage_exact
                                              source text sha256
                                              4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                              start
                                              1576
                                            2. context exact
                                              ents with: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent.
                                              kind
                                              biomarker
                                              polarity
                                              not_inferred
                                              span
                                              end
                                              1659
                                              end exclusive
                                              true
                                              exact text
                                              CD20-positive
                                              label id
                                              7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                              offset unit
                                              unicode_code_points
                                              source array index
                                              0
                                              source field
                                              indications_and_usage_exact
                                              source text sha256
                                              4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                              start
                                              1646
                                            3. context exact
                                              ABNI is indicated for the treatment of adult patients with: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a si
                                              kind
                                              stage_or_setting
                                              polarity
                                              not_inferred
                                              span
                                              end
                                              1619
                                              end exclusive
                                              true
                                              exact text
                                              Relapsed or refractory
                                              label id
                                              7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                              offset unit
                                              unicode_code_points
                                              source array index
                                              0
                                              source field
                                              indications_and_usage_exact
                                              source text sha256
                                              4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                              start
                                              1597
                                            4. context exact
                                              ractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent.
                                              kind
                                              regimen
                                              polarity
                                              not_inferred
                                              span
                                              end
                                              1689
                                              end exclusive
                                              true
                                              exact text
                                              as a single agent
                                              label id
                                              7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                              offset unit
                                              unicode_code_points
                                              source array index
                                              0
                                              source field
                                              indications_and_usage_exact
                                              source text sha256
                                              4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                              start
                                              1672
                                            regulatory links
                                              schema version
                                              0.1.0
                                              source batch sha256
                                              a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                                              source defined aliases
                                                source span
                                                end
                                                1690
                                                end exclusive
                                                true
                                                exact text
                                                1.1 Non-Hodgkin's Lymphoma (NHL) RIABNI is indicated for the treatment of adult patients with: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent.
                                                label id
                                                7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                offset unit
                                                unicode_code_points
                                                source array index
                                                0
                                                source field
                                                indications_and_usage_exact
                                                source text sha256
                                                4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                start
                                                1502
                                                source url
                                                https://api.fda.gov/drug/label.json?search=id%3A%227e0a4bc5-9a5f-4b66-ab41-a4417988ccc2%22
                                                spl effective date
                                                2026-07-22
                                                spl set id
                                                da1c4de7-0e5b-4f72-97ec-7a8d368f085f
                                                spl version
                                                12
                                                structured fields status
                                                not_extracted_no_values_inferred_from_mentions
                                                structured indication
                                                age
                                                Source null
                                                approval pathway
                                                Source null
                                                biomarker and test
                                                Source null
                                                disease stage
                                                Source null
                                                limitations
                                                Source null
                                                line
                                                Source null
                                                prior therapy
                                                Source null
                                                regimen
                                                Source null
                                                tumor histology
                                                Source null
                                                use intent
                                                tumor_directed_candidate
                                                Passage 12 · positive indication candidate
                                                application numbers
                                                1. BLA761140
                                                brand names
                                                1. Riabni
                                                classification reasons
                                                1. inherited_predicate_from_same_label_section_requires_review
                                                2. no_tumor_directed_keyword_in_positive_statement
                                                clinical review status
                                                pending
                                                content role
                                                positive_indication_candidate
                                                context span
                                                end
                                                2145
                                                end exclusive
                                                true
                                                exact text
                                                s ( 1.5 ). 1.1 Non-Hodgkin's Lymphoma (NHL) RIABNI is indicated for the treatment of adult patients with: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untrea
                                                label id
                                                7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                offset unit
                                                unicode_code_points
                                                source array index
                                                0
                                                source field
                                                indications_and_usage_exact
                                                source text sha256
                                                4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                start
                                                1491
                                                current approval status
                                                not_reconciled
                                                duplicate text group
                                                dup-30c2530375f7db6d281f
                                                extraction review status
                                                automated_candidate_pending_source_review
                                                generic names
                                                1. RITUXIMAB-ARRX
                                                id
                                                ind-span-b813ae02ce170bd798a1
                                                label id
                                                7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                positive predicate support span
                                                end
                                                1554
                                                end exclusive
                                                true
                                                exact text
                                                is indicated
                                                label id
                                                7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                offset unit
                                                unicode_code_points
                                                source array index
                                                0
                                                source field
                                                indications_and_usage_exact
                                                source text sha256
                                                4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                start
                                                1542
                                                qualifier mentions
                                                1. context exact
                                                  Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and
                                                  kind
                                                  biomarker
                                                  polarity
                                                  not_inferred
                                                  span
                                                  end
                                                  1737
                                                  end exclusive
                                                  true
                                                  exact text
                                                  CD20-positive
                                                  label id
                                                  7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                  offset unit
                                                  unicode_code_points
                                                  source array index
                                                  0
                                                  source field
                                                  indications_and_usage_exact
                                                  source text sha256
                                                  4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                  start
                                                  1724
                                                2. context exact
                                                  Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent mainte
                                                  kind
                                                  prior_therapy_or_line
                                                  polarity
                                                  not_inferred
                                                  span
                                                  end
                                                  1871
                                                  end exclusive
                                                  true
                                                  exact text
                                                  Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab prod
                                                  label id
                                                  7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                  offset unit
                                                  unicode_code_points
                                                  source array index
                                                  0
                                                  source field
                                                  indications_and_usage_exact
                                                  source text sha256
                                                  4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                  start
                                                  1691
                                                3. context exact
                                                  Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.
                                                  kind
                                                  regimen
                                                  polarity
                                                  not_inferred
                                                  span
                                                  end
                                                  1929
                                                  end exclusive
                                                  true
                                                  exact text
                                                  in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent main
                                                  label id
                                                  7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                  offset unit
                                                  unicode_code_points
                                                  source array index
                                                  0
                                                  source field
                                                  indications_and_usage_exact
                                                  source text sha256
                                                  4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                  start
                                                  1750
                                                regulatory links
                                                  schema version
                                                  0.1.0
                                                  source batch sha256
                                                  a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                                                  source defined aliases
                                                    source span
                                                    end
                                                    1945
                                                    end exclusive
                                                    true
                                                    exact text
                                                    Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.
                                                    label id
                                                    7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                    offset unit
                                                    unicode_code_points
                                                    source array index
                                                    0
                                                    source field
                                                    indications_and_usage_exact
                                                    source text sha256
                                                    4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                    start
                                                    1691
                                                    source url
                                                    https://api.fda.gov/drug/label.json?search=id%3A%227e0a4bc5-9a5f-4b66-ab41-a4417988ccc2%22
                                                    spl effective date
                                                    2026-07-22
                                                    spl set id
                                                    da1c4de7-0e5b-4f72-97ec-7a8d368f085f
                                                    spl version
                                                    12
                                                    structured fields status
                                                    not_extracted_no_values_inferred_from_mentions
                                                    structured indication
                                                    age
                                                    Source null
                                                    approval pathway
                                                    Source null
                                                    biomarker and test
                                                    Source null
                                                    disease stage
                                                    Source null
                                                    limitations
                                                    Source null
                                                    line
                                                    Source null
                                                    prior therapy
                                                    Source null
                                                    regimen
                                                    Source null
                                                    tumor histology
                                                    Source null
                                                    use intent
                                                    non_oncology_or_unclear_candidate
                                                    Passage 13 · unclassified context
                                                    application numbers
                                                    1. BLA761140
                                                    brand names
                                                    1. Riabni
                                                    classification reasons
                                                    1. no_unambiguous_positive_indication_predicate
                                                    clinical review status
                                                    pending
                                                    content role
                                                    unclassified_context
                                                    context span
                                                    end
                                                    2327
                                                    end exclusive
                                                    true
                                                    exact text
                                                    NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens. 1.2
                                                    label id
                                                    7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                    offset unit
                                                    unicode_code_points
                                                    source array index
                                                    0
                                                    source field
                                                    indications_and_usage_exact
                                                    source text sha256
                                                    4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                    start
                                                    1746
                                                    current approval status
                                                    not_reconciled
                                                    duplicate text group
                                                    dup-7f978299f4a92753070e
                                                    extraction review status
                                                    automated_candidate_pending_source_review
                                                    generic names
                                                    1. RITUXIMAB-ARRX
                                                    id
                                                    ind-span-c6122f51b737b2cc16b4
                                                    label id
                                                    7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                    positive predicate support span
                                                    Source null
                                                    qualifier mentions
                                                    1. context exact
                                                      Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophospha
                                                      kind
                                                      biomarker
                                                      polarity
                                                      not_inferred
                                                      span
                                                      end
                                                      2014
                                                      end exclusive
                                                      true
                                                      exact text
                                                      CD20-positive
                                                      label id
                                                      7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                      offset unit
                                                      unicode_code_points
                                                      source array index
                                                      0
                                                      source field
                                                      indications_and_usage_exact
                                                      source text sha256
                                                      4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                      start
                                                      2001
                                                    2. context exact
                                                      ow-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
                                                      kind
                                                      prior_therapy_or_line
                                                      polarity
                                                      not_inferred
                                                      span
                                                      end
                                                      2126
                                                      end exclusive
                                                      true
                                                      exact text
                                                      first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy
                                                      label id
                                                      7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                      offset unit
                                                      unicode_code_points
                                                      source array index
                                                      0
                                                      source field
                                                      indications_and_usage_exact
                                                      source text sha256
                                                      4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                      start
                                                      2051
                                                    3. context exact
                                                      uding stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
                                                      kind
                                                      regimen
                                                      polarity
                                                      not_inferred
                                                      span
                                                      end
                                                      2126
                                                      end exclusive
                                                      true
                                                      exact text
                                                      as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy
                                                      label id
                                                      7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                      offset unit
                                                      unicode_code_points
                                                      source array index
                                                      0
                                                      source field
                                                      indications_and_usage_exact
                                                      source text sha256
                                                      4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                      start
                                                      2027
                                                    regulatory links
                                                      schema version
                                                      0.1.0
                                                      source batch sha256
                                                      a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                                                      source defined aliases
                                                        source span
                                                        end
                                                        2127
                                                        end exclusive
                                                        true
                                                        exact text
                                                        Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
                                                        label id
                                                        7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                        offset unit
                                                        unicode_code_points
                                                        source array index
                                                        0
                                                        source field
                                                        indications_and_usage_exact
                                                        source text sha256
                                                        4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                        start
                                                        1946
                                                        source url
                                                        https://api.fda.gov/drug/label.json?search=id%3A%227e0a4bc5-9a5f-4b66-ab41-a4417988ccc2%22
                                                        spl effective date
                                                        2026-07-22
                                                        spl set id
                                                        da1c4de7-0e5b-4f72-97ec-7a8d368f085f
                                                        spl version
                                                        12
                                                        structured fields status
                                                        not_extracted_no_values_inferred_from_mentions
                                                        structured indication
                                                        age
                                                        Source null
                                                        approval pathway
                                                        Source null
                                                        biomarker and test
                                                        Source null
                                                        disease stage
                                                        Source null
                                                        limitations
                                                        Source null
                                                        line
                                                        Source null
                                                        prior therapy
                                                        Source null
                                                        regimen
                                                        Source null
                                                        tumor histology
                                                        Source null
                                                        use intent
                                                        unclear
                                                        Passage 14 · positive indication candidate
                                                        application numbers
                                                        1. BLA761140
                                                        brand names
                                                        1. Riabni
                                                        classification reasons
                                                        1. inherited_predicate_from_same_label_section_requires_review
                                                        2. no_tumor_directed_keyword_in_positive_statement
                                                        clinical review status
                                                        pending
                                                        content role
                                                        positive_indication_candidate
                                                        context span
                                                        end
                                                        2522
                                                        end exclusive
                                                        true
                                                        exact text
                                                        ntenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens. 1.2 Chronic Lymphocytic Leukemia (CLL) RIABNI, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously tre
                                                        label id
                                                        7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                        offset unit
                                                        unicode_code_points
                                                        source array index
                                                        0
                                                        source field
                                                        indications_and_usage_exact
                                                        source text sha256
                                                        4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                        start
                                                        1928
                                                        current approval status
                                                        not_reconciled
                                                        duplicate text group
                                                        dup-62a55929f06a7b7e46f1
                                                        extraction review status
                                                        automated_candidate_pending_source_review
                                                        generic names
                                                        1. RITUXIMAB-ARRX
                                                        id
                                                        ind-span-6d8151c70cd4385c6299
                                                        label id
                                                        7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                        positive predicate support span
                                                        end
                                                        1554
                                                        end exclusive
                                                        true
                                                        exact text
                                                        is indicated
                                                        label id
                                                        7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                        offset unit
                                                        unicode_code_points
                                                        source array index
                                                        0
                                                        source field
                                                        indications_and_usage_exact
                                                        source text sha256
                                                        4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                        start
                                                        1542
                                                        qualifier mentions
                                                        1. context exact
                                                          Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or o
                                                          kind
                                                          biomarker
                                                          polarity
                                                          not_inferred
                                                          span
                                                          end
                                                          2215
                                                          end exclusive
                                                          true
                                                          exact text
                                                          CD20-positive NHL in combination with cyclop
                                                          label id
                                                          7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                          offset unit
                                                          unicode_code_points
                                                          source array index
                                                          0
                                                          source field
                                                          indications_and_usage_exact
                                                          source text sha256
                                                          4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                          start
                                                          2171
                                                        2. context exact
                                                          Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
                                                          kind
                                                          prior_therapy_or_line
                                                          polarity
                                                          not_inferred
                                                          span
                                                          end
                                                          2308
                                                          end exclusive
                                                          true
                                                          exact text
                                                          Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemothe
                                                          label id
                                                          7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                          offset unit
                                                          unicode_code_points
                                                          source array index
                                                          0
                                                          source field
                                                          indications_and_usage_exact
                                                          source text sha256
                                                          4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                          start
                                                          2128
                                                        3. context exact
                                                          reviously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
                                                          kind
                                                          regimen
                                                          polarity
                                                          not_inferred
                                                          span
                                                          end
                                                          2321
                                                          end exclusive
                                                          true
                                                          exact text
                                                          in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens
                                                          label id
                                                          7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                          offset unit
                                                          unicode_code_points
                                                          source array index
                                                          0
                                                          source field
                                                          indications_and_usage_exact
                                                          source text sha256
                                                          4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                          start
                                                          2189
                                                        regulatory links
                                                          schema version
                                                          0.1.0
                                                          source batch sha256
                                                          a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                                                          source defined aliases
                                                            source span
                                                            end
                                                            2322
                                                            end exclusive
                                                            true
                                                            exact text
                                                            Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
                                                            label id
                                                            7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                            offset unit
                                                            unicode_code_points
                                                            source array index
                                                            0
                                                            source field
                                                            indications_and_usage_exact
                                                            source text sha256
                                                            4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                            start
                                                            2128
                                                            source url
                                                            https://api.fda.gov/drug/label.json?search=id%3A%227e0a4bc5-9a5f-4b66-ab41-a4417988ccc2%22
                                                            spl effective date
                                                            2026-07-22
                                                            spl set id
                                                            da1c4de7-0e5b-4f72-97ec-7a8d368f085f
                                                            spl version
                                                            12
                                                            structured fields status
                                                            not_extracted_no_values_inferred_from_mentions
                                                            structured indication
                                                            age
                                                            Source null
                                                            approval pathway
                                                            Source null
                                                            biomarker and test
                                                            Source null
                                                            disease stage
                                                            Source null
                                                            limitations
                                                            Source null
                                                            line
                                                            Source null
                                                            prior therapy
                                                            Source null
                                                            regimen
                                                            Source null
                                                            tumor histology
                                                            Source null
                                                            use intent
                                                            non_oncology_or_unclear_candidate
                                                            Passage 15 · positive indication candidate
                                                            application numbers
                                                            1. BLA761140
                                                            brand names
                                                            1. Riabni
                                                            classification reasons
                                                            1. explicit_positive_indication_predicate
                                                            2. tumor_or_malignant_hematology_words_in_positive_statement
                                                            clinical review status
                                                            pending
                                                            content role
                                                            positive_indication_candidate
                                                            context span
                                                            end
                                                            2745
                                                            end exclusive
                                                            true
                                                            exact text
                                                            apy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens. 1.2 Chronic Lymphocytic Leukemia (CLL) RIABNI, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL. 1.3 Rheumatoid Arthritis (RA) RIABNI, in combination with methotrexate, is indicated for the treatment of adult patients with moderately- to-severely- active rheumatoid arthritis who have had an inad
                                                            label id
                                                            7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                            offset unit
                                                            unicode_code_points
                                                            source array index
                                                            0
                                                            source field
                                                            indications_and_usage_exact
                                                            source text sha256
                                                            4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                            start
                                                            2123
                                                            current approval status
                                                            not_reconciled
                                                            duplicate text group
                                                            dup-7c696830209cb4724828
                                                            extraction review status
                                                            automated_candidate_pending_source_review
                                                            generic names
                                                            1. RITUXIMAB-ARRX
                                                            id
                                                            ind-span-8c13143ddf7deb6b1478
                                                            label id
                                                            7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                            positive predicate support span
                                                            end
                                                            2441
                                                            end exclusive
                                                            true
                                                            exact text
                                                            is indicated
                                                            label id
                                                            7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                            offset unit
                                                            unicode_code_points
                                                            source array index
                                                            0
                                                            source field
                                                            indications_and_usage_exact
                                                            source text sha256
                                                            4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                            start
                                                            2429
                                                            qualifier mentions
                                                            1. context exact
                                                              nd cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-posit
                                                              kind
                                                              age
                                                              polarity
                                                              not_inferred
                                                              span
                                                              end
                                                              2477
                                                              end exclusive
                                                              true
                                                              exact text
                                                              adult patients
                                                              label id
                                                              7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                              offset unit
                                                              unicode_code_points
                                                              source array index
                                                              0
                                                              source field
                                                              indications_and_usage_exact
                                                              source text sha256
                                                              4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                              start
                                                              2463
                                                            2. context exact
                                                              t patients with previously untreated and previously treated CD20-positive CLL.
                                                              kind
                                                              biomarker
                                                              polarity
                                                              not_inferred
                                                              span
                                                              end
                                                              2544
                                                              end exclusive
                                                              true
                                                              exact text
                                                              CD20-positive CLL
                                                              label id
                                                              7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                              offset unit
                                                              unicode_code_points
                                                              source array index
                                                              0
                                                              source field
                                                              indications_and_usage_exact
                                                              source text sha256
                                                              4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                              start
                                                              2527
                                                            3. context exact
                                                              (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL.
                                                              kind
                                                              prior_therapy_or_line
                                                              polarity
                                                              not_inferred
                                                              span
                                                              end
                                                              2544
                                                              end exclusive
                                                              true
                                                              exact text
                                                              previously untreated and previously treated CD20-positive CLL
                                                              label id
                                                              7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                              offset unit
                                                              unicode_code_points
                                                              source array index
                                                              0
                                                              source field
                                                              indications_and_usage_exact
                                                              source text sha256
                                                              4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                              start
                                                              2483
                                                            4. context exact
                                                              1.2 Chronic Lymphocytic Leukemia (CLL) RIABNI, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL.
                                                              kind
                                                              regimen
                                                              polarity
                                                              not_inferred
                                                              span
                                                              end
                                                              2544
                                                              end exclusive
                                                              true
                                                              exact text
                                                              in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL
                                                              label id
                                                              7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                              offset unit
                                                              unicode_code_points
                                                              source array index
                                                              0
                                                              source field
                                                              indications_and_usage_exact
                                                              source text sha256
                                                              4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                              start
                                                              2370
                                                            regulatory links
                                                              schema version
                                                              0.1.0
                                                              source batch sha256
                                                              a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                                                              source defined aliases
                                                                source span
                                                                end
                                                                2545
                                                                end exclusive
                                                                true
                                                                exact text
                                                                1.2 Chronic Lymphocytic Leukemia (CLL) RIABNI, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL.
                                                                label id
                                                                7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                                offset unit
                                                                unicode_code_points
                                                                source array index
                                                                0
                                                                source field
                                                                indications_and_usage_exact
                                                                source text sha256
                                                                4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                                start
                                                                2323
                                                                source url
                                                                https://api.fda.gov/drug/label.json?search=id%3A%227e0a4bc5-9a5f-4b66-ab41-a4417988ccc2%22
                                                                spl effective date
                                                                2026-07-22
                                                                spl set id
                                                                da1c4de7-0e5b-4f72-97ec-7a8d368f085f
                                                                spl version
                                                                12
                                                                structured fields status
                                                                not_extracted_no_values_inferred_from_mentions
                                                                structured indication
                                                                age
                                                                Source null
                                                                approval pathway
                                                                Source null
                                                                biomarker and test
                                                                Source null
                                                                disease stage
                                                                Source null
                                                                limitations
                                                                Source null
                                                                line
                                                                Source null
                                                                prior therapy
                                                                Source null
                                                                regimen
                                                                Source null
                                                                tumor histology
                                                                Source null
                                                                use intent
                                                                tumor_directed_candidate
                                                                Passage 16 · positive indication candidate
                                                                application numbers
                                                                1. BLA761140
                                                                brand names
                                                                1. Riabni
                                                                classification reasons
                                                                1. explicit_positive_indication_predicate
                                                                2. no_tumor_directed_keyword_in_positive_statement
                                                                clinical review status
                                                                pending
                                                                content role
                                                                positive_indication_candidate
                                                                context span
                                                                end
                                                                3001
                                                                end exclusive
                                                                true
                                                                exact text
                                                                Leukemia (CLL) RIABNI, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL. 1.3 Rheumatoid Arthritis (RA) RIABNI, in combination with methotrexate, is indicated for the treatment of adult patients with moderately- to-severely- active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. 1.4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) RIABNI, in combination with glucocorticoids, is indicated for the treatment of adult patients
                                                                label id
                                                                7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                                offset unit
                                                                unicode_code_points
                                                                source array index
                                                                0
                                                                source field
                                                                indications_and_usage_exact
                                                                source text sha256
                                                                4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                                start
                                                                2346
                                                                current approval status
                                                                not_reconciled
                                                                duplicate text group
                                                                dup-9e355f56c8516dba1669
                                                                extraction review status
                                                                automated_candidate_pending_source_review
                                                                generic names
                                                                1. RITUXIMAB-ARRX
                                                                id
                                                                ind-span-843ecdf672e3510fa1d3
                                                                label id
                                                                7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                                positive predicate support span
                                                                end
                                                                2630
                                                                end exclusive
                                                                true
                                                                exact text
                                                                is indicated
                                                                label id
                                                                7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                                offset unit
                                                                unicode_code_points
                                                                source array index
                                                                0
                                                                source field
                                                                indications_and_usage_exact
                                                                source text sha256
                                                                4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                                start
                                                                2618
                                                                qualifier mentions
                                                                1. context exact
                                                                  nation with methotrexate, is indicated for the treatment of adult patients with moderately- to-severely- active rheumatoid arthritis w
                                                                  kind
                                                                  age
                                                                  polarity
                                                                  not_inferred
                                                                  span
                                                                  end
                                                                  2666
                                                                  end exclusive
                                                                  true
                                                                  exact text
                                                                  adult patients
                                                                  label id
                                                                  7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                                  offset unit
                                                                  unicode_code_points
                                                                  source array index
                                                                  0
                                                                  source field
                                                                  indications_and_usage_exact
                                                                  source text sha256
                                                                  4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                                  start
                                                                  2652
                                                                2. context exact
                                                                  1.3 Rheumatoid Arthritis (RA) RIABNI, in combination with methotrexate, is indicated for the treatment of adult patients with mode
                                                                  kind
                                                                  biomarker
                                                                  polarity
                                                                  not_inferred
                                                                  span
                                                                  end
                                                                  2616
                                                                  end exclusive
                                                                  true
                                                                  exact text
                                                                  methotrexate
                                                                  label id
                                                                  7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                                  offset unit
                                                                  unicode_code_points
                                                                  source array index
                                                                  0
                                                                  source field
                                                                  indications_and_usage_exact
                                                                  source text sha256
                                                                  4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                                  start
                                                                  2604
                                                                3. context exact
                                                                  1.3 Rheumatoid Arthritis (RA) RIABNI, in combination with methotrexate, is indicated for the treatment of adult patients with moderately- to-severely- active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.
                                                                  kind
                                                                  regimen
                                                                  polarity
                                                                  not_inferred
                                                                  span
                                                                  end
                                                                  2763
                                                                  end exclusive
                                                                  true
                                                                  exact text
                                                                  in combination with methotrexate, is indicated for the treatment of adult patients with moderately- to-severely- active rheumatoid arthritis who have had an inadequate response to
                                                                  label id
                                                                  7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                                  offset unit
                                                                  unicode_code_points
                                                                  source array index
                                                                  0
                                                                  source field
                                                                  indications_and_usage_exact
                                                                  source text sha256
                                                                  4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                                  start
                                                                  2584
                                                                regulatory links
                                                                  schema version
                                                                  0.1.0
                                                                  source batch sha256
                                                                  a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                                                                  source defined aliases
                                                                    source span
                                                                    end
                                                                    2801
                                                                    end exclusive
                                                                    true
                                                                    exact text
                                                                    1.3 Rheumatoid Arthritis (RA) RIABNI, in combination with methotrexate, is indicated for the treatment of adult patients with moderately- to-severely- active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.
                                                                    label id
                                                                    7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                                    offset unit
                                                                    unicode_code_points
                                                                    source array index
                                                                    0
                                                                    source field
                                                                    indications_and_usage_exact
                                                                    source text sha256
                                                                    4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                                    start
                                                                    2546
                                                                    source url
                                                                    https://api.fda.gov/drug/label.json?search=id%3A%227e0a4bc5-9a5f-4b66-ab41-a4417988ccc2%22
                                                                    spl effective date
                                                                    2026-07-22
                                                                    spl set id
                                                                    da1c4de7-0e5b-4f72-97ec-7a8d368f085f
                                                                    spl version
                                                                    12
                                                                    structured fields status
                                                                    not_extracted_no_values_inferred_from_mentions
                                                                    structured indication
                                                                    age
                                                                    Source null
                                                                    approval pathway
                                                                    Source null
                                                                    biomarker and test
                                                                    Source null
                                                                    disease stage
                                                                    Source null
                                                                    limitations
                                                                    Source null
                                                                    line
                                                                    Source null
                                                                    prior therapy
                                                                    Source null
                                                                    regimen
                                                                    Source null
                                                                    tumor histology
                                                                    Source null
                                                                    use intent
                                                                    non_oncology_or_unclear_candidate
                                                                    Passage 17 · positive indication candidate
                                                                    application numbers
                                                                    1. BLA761140
                                                                    brand names
                                                                    1. Riabni
                                                                    classification reasons
                                                                    1. explicit_positive_indication_predicate
                                                                    2. no_tumor_directed_keyword_in_positive_statement
                                                                    clinical review status
                                                                    pending
                                                                    content role
                                                                    positive_indication_candidate
                                                                    context span
                                                                    end
                                                                    3235
                                                                    end exclusive
                                                                    true
                                                                    exact text
                                                                    h methotrexate, is indicated for the treatment of adult patients with moderately- to-severely- active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. 1.4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) RIABNI, in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA). 1.5 Pemphigus Vulgaris (PV) RIABNI is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.
                                                                    label id
                                                                    7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                                    offset unit
                                                                    unicode_code_points
                                                                    source array index
                                                                    0
                                                                    source field
                                                                    indications_and_usage_exact
                                                                    source text sha256
                                                                    4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                                    start
                                                                    2602
                                                                    current approval status
                                                                    not_reconciled
                                                                    duplicate text group
                                                                    dup-ae1f57913f13eb329343
                                                                    extraction review status
                                                                    automated_candidate_pending_source_review
                                                                    generic names
                                                                    1. RITUXIMAB-ARRX
                                                                    id
                                                                    ind-span-66831ea0005e55e412aa
                                                                    label id
                                                                    7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                                    positive predicate support span
                                                                    end
                                                                    2964
                                                                    end exclusive
                                                                    true
                                                                    exact text
                                                                    is indicated
                                                                    label id
                                                                    7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                                    offset unit
                                                                    unicode_code_points
                                                                    source array index
                                                                    0
                                                                    source field
                                                                    indications_and_usage_exact
                                                                    source text sha256
                                                                    4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                                    start
                                                                    2952
                                                                    qualifier mentions
                                                                    1. context exact
                                                                      ion with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener's Gran
                                                                      kind
                                                                      age
                                                                      polarity
                                                                      not_inferred
                                                                      span
                                                                      end
                                                                      3000
                                                                      end exclusive
                                                                      true
                                                                      exact text
                                                                      adult patients
                                                                      label id
                                                                      7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                                      offset unit
                                                                      unicode_code_points
                                                                      source array index
                                                                      0
                                                                      source field
                                                                      indications_and_usage_exact
                                                                      source text sha256
                                                                      4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                                      start
                                                                      2986
                                                                    2. context exact
                                                                      Granulomatosis) and Microscopic Polyangiitis (MPA) RIABNI, in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA).
                                                                      kind
                                                                      regimen
                                                                      polarity
                                                                      not_inferred
                                                                      span
                                                                      end
                                                                      3094
                                                                      end exclusive
                                                                      true
                                                                      exact text
                                                                      in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyan
                                                                      label id
                                                                      7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                                      offset unit
                                                                      unicode_code_points
                                                                      source array index
                                                                      0
                                                                      source field
                                                                      indications_and_usage_exact
                                                                      source text sha256
                                                                      4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                                      start
                                                                      2915
                                                                    regulatory links
                                                                      schema version
                                                                      0.1.0
                                                                      source batch sha256
                                                                      a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                                                                      source defined aliases
                                                                        source span
                                                                        end
                                                                        3107
                                                                        end exclusive
                                                                        true
                                                                        exact text
                                                                        1.4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) RIABNI, in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA).
                                                                        label id
                                                                        7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                                        offset unit
                                                                        unicode_code_points
                                                                        source array index
                                                                        0
                                                                        source field
                                                                        indications_and_usage_exact
                                                                        source text sha256
                                                                        4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                                        start
                                                                        2802
                                                                        source url
                                                                        https://api.fda.gov/drug/label.json?search=id%3A%227e0a4bc5-9a5f-4b66-ab41-a4417988ccc2%22
                                                                        spl effective date
                                                                        2026-07-22
                                                                        spl set id
                                                                        da1c4de7-0e5b-4f72-97ec-7a8d368f085f
                                                                        spl version
                                                                        12
                                                                        structured fields status
                                                                        not_extracted_no_values_inferred_from_mentions
                                                                        structured indication
                                                                        age
                                                                        Source null
                                                                        approval pathway
                                                                        Source null
                                                                        biomarker and test
                                                                        Source null
                                                                        disease stage
                                                                        Source null
                                                                        limitations
                                                                        Source null
                                                                        line
                                                                        Source null
                                                                        prior therapy
                                                                        Source null
                                                                        regimen
                                                                        Source null
                                                                        tumor histology
                                                                        Source null
                                                                        use intent
                                                                        non_oncology_or_unclear_candidate
                                                                        Passage 18 · positive indication candidate
                                                                        application numbers
                                                                        1. BLA761140
                                                                        brand names
                                                                        1. Riabni
                                                                        classification reasons
                                                                        1. explicit_positive_indication_predicate
                                                                        2. no_tumor_directed_keyword_in_positive_statement
                                                                        clinical review status
                                                                        pending
                                                                        content role
                                                                        positive_indication_candidate
                                                                        context span
                                                                        end
                                                                        3235
                                                                        end exclusive
                                                                        true
                                                                        exact text
                                                                        IABNI, in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA). 1.5 Pemphigus Vulgaris (PV) RIABNI is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.
                                                                        label id
                                                                        7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                                        offset unit
                                                                        unicode_code_points
                                                                        source array index
                                                                        0
                                                                        source field
                                                                        indications_and_usage_exact
                                                                        source text sha256
                                                                        4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                                        start
                                                                        2908
                                                                        current approval status
                                                                        not_reconciled
                                                                        duplicate text group
                                                                        dup-804153f9f720f0b2847e
                                                                        extraction review status
                                                                        automated_candidate_pending_source_review
                                                                        generic names
                                                                        1. RITUXIMAB-ARRX
                                                                        id
                                                                        ind-span-e7b70264d8d13564e476
                                                                        label id
                                                                        7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                                        positive predicate support span
                                                                        end
                                                                        3155
                                                                        end exclusive
                                                                        true
                                                                        exact text
                                                                        is indicated
                                                                        label id
                                                                        7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                                        offset unit
                                                                        unicode_code_points
                                                                        source array index
                                                                        0
                                                                        source field
                                                                        indications_and_usage_exact
                                                                        source text sha256
                                                                        4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                                        start
                                                                        3143
                                                                        qualifier mentions
                                                                        1. context exact
                                                                          igus Vulgaris (PV) RIABNI is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.
                                                                          kind
                                                                          age
                                                                          polarity
                                                                          not_inferred
                                                                          span
                                                                          end
                                                                          3191
                                                                          end exclusive
                                                                          true
                                                                          exact text
                                                                          adult patients
                                                                          label id
                                                                          7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                                          offset unit
                                                                          unicode_code_points
                                                                          source array index
                                                                          0
                                                                          source field
                                                                          indications_and_usage_exact
                                                                          source text sha256
                                                                          4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                                          start
                                                                          3177
                                                                        regulatory links
                                                                          schema version
                                                                          0.1.0
                                                                          source batch sha256
                                                                          a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                                                                          source defined aliases
                                                                            source span
                                                                            end
                                                                            3235
                                                                            end exclusive
                                                                            true
                                                                            exact text
                                                                            1.5 Pemphigus Vulgaris (PV) RIABNI is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.
                                                                            label id
                                                                            7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2
                                                                            offset unit
                                                                            unicode_code_points
                                                                            source array index
                                                                            0
                                                                            source field
                                                                            indications_and_usage_exact
                                                                            source text sha256
                                                                            4568639e6ef79489beb81689ecd5825ad049b282606183640f464f60391dc2de
                                                                            start
                                                                            3108
                                                                            source url
                                                                            https://api.fda.gov/drug/label.json?search=id%3A%227e0a4bc5-9a5f-4b66-ab41-a4417988ccc2%22
                                                                            spl effective date
                                                                            2026-07-22
                                                                            spl set id
                                                                            da1c4de7-0e5b-4f72-97ec-7a8d368f085f
                                                                            spl version
                                                                            12
                                                                            structured fields status
                                                                            not_extracted_no_values_inferred_from_mentions
                                                                            structured indication
                                                                            age
                                                                            Source null
                                                                            approval pathway
                                                                            Source null
                                                                            biomarker and test
                                                                            Source null
                                                                            disease stage
                                                                            Source null
                                                                            limitations
                                                                            Source null
                                                                            line
                                                                            Source null
                                                                            prior therapy
                                                                            Source null
                                                                            regimen
                                                                            Source null
                                                                            tumor histology
                                                                            Source null
                                                                            use intent
                                                                            non_oncology_or_unclear_candidate

                                                                            Preserved source evidence · Not medical advice